Teva Pharmaceutical Industries has signed a license agreement with Alder BioPharmaceuticals, a Bothell, Washington-headquartered clinical-stage biopharmaceutical company, to develop, manufacture, and commercialize Alder’s investigational migraine drug, eptinezumab.

The agreement resolves Alder’s opposition to Teva’s European patent regarding anti-calcitonin gene-related peptide (CGRP) antibodies and methods for their use.

Under the agreement, Alder has received a non-exclusive license to Teva’s anti-CGRP antibodies patent portfolio to develop, manufacture, and commercialize eptinezumab in the US and worldwide, excluding Japan and Korea.

In exchange, Alder has agreed to: (1) withdraw its appeal before the European Patent Office; (2) make an immediate one-time payment of $25 million to Teva; (3) make a second one-time payment of $25 million upon the approval of a biologics license application for Alder’s eptinezumab with the US Food and Drug Administration or of an earlier equivalent filing with a regulatory authority elsewhere in the license territory in which any Teva licensed patents exist; (4) following commercial launch of eptinezumab, pay $75 million at each of two sales-related milestones (at $1 billion and $2 billion in sales achieved in a calendar year); and (5) provide certain royalty payments on net sales at rates from 5% to 7%.

Source: Teva Pharmaceutical Industries